MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

Catalog Number RBY4C0305

Device Problem Premature Separation (4045)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the hepatic artery using ruby coils.During the procedure, the physician placed a ruby coil in the target vessel using a lantern delivery microcatheter (lantern).While advancing another ruby coil into the target vessel, the ruby coil was kicking the lantern kicked out of the aneurysm and into the proper hepatic artery; therefore, the ruby coil was retracted.However, while retracting, the ruby coil unintentionally detached, with part of the coil in the aneurysm and the other part in the lantern.The physician attempted to remove the lantern with aspiration to secure the detached ruby coil; however, the ruby coil ended up in the common hepatic artery and celiac trunk.A snare device was then used to remove the detached ruby coil; however, the coil was pushed by the flow of the vessel from the aneurysm into the proper hepatic artery and gastroduodenal artery (gda).The physician decided to end the procedure and leave the detached coil as a non-targeted embodiment in order to avoid further complications.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 9310733
• MDR Text Key: 166014047
• Report Number: 3005168196-2019-02110
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018317
• UDI-Public: 00814548018317
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F92026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention